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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65646
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution including the states of IL, KY and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well. Catalog Number- 33250400S Catalog Number 33250360S Class II Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. 5 units Z-1846-2013